Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries

NCT07311785 | Not Yet Recruiting

• 1 other identifier: Omfs 3-3-19
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. The main question it aims to answer is:

• Is the minimally invasive approach accurate and stable ? Researchers will compare minimally invasive technique to the traditional technique of fixation of the maxilla bone to see if it is as accurate and stable. Participants will:
• Undergo surgey
• Follow up visits weekly for a month then on a monthly basis for 5 more months.

Conditions

Orthognathic Surgery

Keywords

orthognathic; minimally invasive; nasal buttress; custom plate

Outcome Measures

Primary Outcomes (1)

• Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.

  linear measurement of discrepancy between both scans after superimposition

  from preoperative plan to immediate postoperative (1 week)

Secondary Outcomes (1)

• Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans

  from enrollment to 6 month postoperative

Study Arms (2)

intervention

EXPERIMENTAL

Maxilla fixation using custom plates on nasal buttress only via minimally invasive approach.

Procedure: minimally invasive maxillary fixation

control

ACTIVE COMPARATOR

Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.

Procedure: Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.

Interventions

minimally invasive maxillary fixation PROCEDURE

3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress

Also known as: 2 plates maxillary fixation

intervention

Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach. PROCEDURE

3d printed custom plates fixing maxilla on nasal and zygomatic buttresses via conventional vestibular approach.

control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
• Patients with no signs or symptoms of active TMDs.
• Highly motivated patients.

You may not qualify if:

• Patients who refused to be included in the research.
• Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
• Patients with intra-bony lesions or infections that may retard the osteotomy healing.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Mahmoud H Khorshed, MSc

CONTACT

00201002007644; mahmoud.khorshed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: oral & maxillofacial surgeon

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12